FDA.reportPublic FDA data

LEGION

Primary DI
00380657530274
Brand
LEGION
Company
Alcon Laboratories, Inc.
Model
8065753027
Device description
LEGION System, FMS BASIC
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQCUnit, Phacofragmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380657530271PackageGS16In Commercial Distribution
00380657530274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065753027110380657530271
00380657530274003806575302743806575302740380657530274

Regulatory Flags#

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380658560270CLAREON VIVITY PROVNYWT0VNYWT0-0602026-11-02
00380658560287CLAREON VIVITY PROVNYWT0VNYWT0-0652026-11-02
00380658560294CLAREON VIVITY PROVNYWT0VNYWT0-0702026-11-02
00380658560300CLAREON VIVITY PROVNYWT0VNYWT0-0752026-11-02
00380658560317CLAREON VIVITY PROVNYWT0VNYWT0-0802026-11-02
00380658560324CLAREON VIVITY PROVNYWT0VNYWT0-0852026-11-02
00380658560331CLAREON VIVITY PROVNYWT0VNYWT0-0902026-11-02
00380658560348CLAREON VIVITY PROVNYWT0VNYWT0-0952026-11-02
00380658560355CLAREON VIVITY PROVNYWT0VNYWT0-1002026-11-02
00380658560362CLAREON VIVITY PROVNYWT0VNYWT0-1052026-11-02
00380658560379CLAREON VIVITY PROVNYWT0VNYWT0-1102026-11-02
00380658560386CLAREON VIVITY PROVNYWT0VNYWT0-1152026-11-02
00380658560393CLAREON VIVITY PROVNYWT0VNYWT0-1202026-11-02
00380658560409CLAREON VIVITY PROVNYWT0VNYWT0-1252026-11-02
00380658560416CLAREON VIVITY PROVNYWT0VNYWT0-1302026-11-02
00380658560423CLAREON VIVITY PROVNYWT0VNYWT0-1352026-11-02
00380658560430CLAREON VIVITY PROVNYWT0VNYWT0-1402026-11-02
00380658560447CLAREON VIVITY PROVNYWT0VNYWT0-1452026-11-02
00380658560454CLAREON VIVITY PROVNYWT0VNYWT0-1502026-11-02
00380658560461CLAREON VIVITY PROVNYWT0VNYWT0-1552026-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380657530281LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530298LEGION, INTREPIDAlcon Laboratories, Inc.HQC2026-07-22
00380657530373LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530502LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530564LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530755LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657531639LEGION, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531646LEGION, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531653LEGION, INTREPID, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531660LEGION, INTREPID, KELMANAlcon Laboratories, Inc.HQC2026-07-22
07630055210319Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210326Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210333Phaco Set Sophi - 23G/30°This AGHQC2026-02-11
07630055210807Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210814Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210821Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055252883HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055253293Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410762Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410786Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410809Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
08717872035390Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035413TotalView Endoillumination Probe, including illuminated scleral depressor.(27 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035437Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
0871787203553627G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035604Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036588Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036595Disposable EVA DrapesD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036601Disposable EVA VGPC Input SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31